Real-time Margin Assessment in Head and Neck Cancer

Inclusion Criteria:

• Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma andscheduled to undergo surgical removal as decided by the multidisciplinary head andneck tumor board of the UMCG;
• Age ≥ 18 years;
• Written informed consent.

Exclusion Criteria:

• Medical or psychiatric conditions that compromise the patient's ability to giveinformed consent;
• Concurrent uncontrolled medical conditions;
• Received an investigational drug within 30 days prior to the dose of cetuximab-800CW;
• History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heartfailure, significant liver disease (ALT >3X upper limits of normal or increased totalbilirubin) or unstable angina within 6 months prior to enrollment;
• Inadequately controlled hypertension with or without current antihypertensivemedications;
• History of allergy or infusion reactions cetuximab or other monoclonal antibodytherapies;
• Pregnant or lactating women. Documentation of a negative pregnancy test must beavailable for women of childbearing potential. Moreover, the need to be willing toensure that she or her partner uses effective contraception during the trial and for 6months thereafter. Woman of childbearing potential are premenopausal women with intactreproductive organs and women less than two years after menopause;
• Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males orgreater than 450 ms in females)
• Patients receiving Class 1a (quinidine, procainamide) or Class III (dofetilide,amiodarone, sotalol) antiarrhythmic agents.
• Life expectancy < 12 weeks;